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基于信仰的干预措施对尼日利亚三级新生儿单位非医嘱出院率的影响:一项开放标签随机对照试验方案。

Effectiveness of Faith-Based Interventions on the Rate of Discharged Against Medical Advice in Tertiary Newborn Units in Nigeria: A Protocol for an Open Label Randomized Control Trial.

机构信息

Department of Paediatrics, University College Hospital Ibadan, Ibadan, Nigeria.

Department of Paediatrics, Federal Medical Centre, Katsina, Nigeria.

出版信息

Front Public Health. 2022 Feb 1;9:788383. doi: 10.3389/fpubh.2021.788383. eCollection 2021.

Abstract

BACKGROUND

Discharged against medical advice (DAMA) is a risk factor that often leads to adverse outcomes and hospital readmissions in neonatal units. A few studies have shown that spiritual/faith-based interventions (FBIs) tend to have a lower incidence of DAMA compared with public hospitals. Perhaps, a holistic approach to patient care that addresses the spiritual needs, the soul and the body component of a being in this setting may account for the observed lower incidence of DAMA. Limited randomized control trials (RCTs) exist on FBIs with regard to DAMA in the published literature. This study seeks to compare the effectiveness of FBI, social support, religiosity, and types of FBI on neonatal DAMA against standard of care in tertiary hospitals in Nigeria.

METHODS

This RCT will be conducted in two public tertiary teaching hospitals in two of the six geopolitical zones in Nigeria. The sociodemographic and clinical details of all patients admitted to the neonatal wards during the study period will be documented. Study participants will be selected through a multistage sampling technique. Subjects will be randomized and allocated to treatment and control arms having the established baseline measure of social support and religiosity. Ethical approval was obtained from the State Research Ethics Review Committee. A written informed consent will be obtained from the parents/caregivers prior to patient enrolment. The study will be conducted in line with the Declaration of Hesinki 2000. Appropriate statistical tools will be used for data collection and analysis.

DISCUSSION

The outcome of this analysis will give insights into the effectiveness of FBI on DAMA. It will also predict the effect of the mediators of parents/caregivers' religiosity, spirituality, forms of FBI, the religious sect of parents/caregivers, and social support on the rate of DAMA on neonatal admission in tertiary hospitals in Nigeria. This could help Public Health Institutions and Governments make decisions about the determinants of neonatal DAMA and how to mitigate such outcomes. It is hoped that the evidence from this study may guide policy formulation and guidelines on enhancing hospital retention of sick neonates until they are fit for discharge.

TRIAL REGISTRATION

This study was registered at the Pan Africa Clinical Trial Registry (PACTR202102670906630).

摘要

背景

违背医嘱出院(DAMA)是导致新生儿病房出现不良后果和再次入院的一个风险因素。一些研究表明,与公立医院相比,精神/信仰干预(FBI)往往可以降低 DAMA 的发生率。也许,在这种情况下,采用整体方法来满足患者的护理需求,解决精神需求、灵魂和身体这三个方面,可能是导致 DAMA 发生率较低的原因。关于 FBI 对新生儿 DAMA 的影响,已发表的文献中仅有有限的随机对照试验(RCT)。本研究旨在比较 FBI、社会支持、宗教信仰以及不同类型的 FBI 对尼日利亚三级医院中标准护理的新生儿 DAMA 的效果。

方法

本 RCT 将在尼日利亚六个地缘政治区中的两个区的两所公立三级教学医院进行。在研究期间,将记录所有入住新生儿病房的患者的社会人口统计学和临床详细信息。研究参与者将通过多级抽样技术进行选择。受试者将随机分配到治疗组和对照组,两组在进行治疗前均进行社会支持和宗教信仰的基线测量。本研究已获得州研究伦理审查委员会的批准。在患者入组前,将获得父母/照顾者的书面知情同意。该研究将按照《赫尔辛基宣言 2000 年》进行。将使用适当的统计工具进行数据收集和分析。

讨论

该分析的结果将深入了解 FBI 对 DAMA 的影响。它还将预测父母/照顾者的宗教信仰、精神信仰、FBI 形式、父母/照顾者的宗教派别以及社会支持对尼日利亚三级医院新生儿 DAMA 发生率的影响。这可以帮助公共卫生机构和政府了解新生儿 DAMA 的决定因素以及如何减轻此类结果。希望本研究的证据可以为制定政策和指导方针提供依据,以增强医院对患病新生儿的保留能力,直到他们适合出院。

试验注册

本研究已在泛非临床试验注册处(PACTR202102670906630)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/f2e2/8843870/1f30c6f14b83/fpubh-09-788383-g0001.jpg

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